Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

NCT ID: NCT00679523

Last Updated: 2018-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-02-28

Brief Summary

The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

Detailed Description

The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 5% AN2690 Solution. Provided that there is adequate evidence of clinical safety after two weeks of dosing with 5% AN2690 Solution, a second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 7.5% AN2690 Solution. A third group of 30 subjects will be enrolled and assigned the highest safe concentration of AN2690 evaluated in this study.

Conditions

Onychomycosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Group 1

AN2690 Solution, 5.0%

Group Type: EXPERIMENTAL

AN2690 Solution, 5.0%

Intervention Type: DRUG

Once daily application for 180 days

Group 2

AN2690 Solution, 7.5%

Group Type: EXPERIMENTAL

AN2690 Solution, 7.5%

Intervention Type: DRUG

Once daily application for 180 days

Interventions

AN2690 Solution, 5.0%

Once daily application for 180 days

Intervention Type: DRUG

AN2690 Solution, 7.5%

Once daily application for 180 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Witnessed, signed informed consent approved by Ethics Committee

2. Male or female subjects of any race at least 18 years of age but not older than 65 years of age at the time of screening

3. Subjects with a diagnosis of onychomycosis of at least one great toenail and with a positive KOH wet mount from that nail

4. Onychomycosis involving 20-60% of the affected great toenail as determined by visual inspection after the nail has been trimmed

5. The combined thickness of the distal nail plate and the associated hyperkeratotic nail bed <3 mm

6. Affected great toenail to be treated is capable of re-growth as documented by history or recent observation of at least 2 mm of growth

7. Normal or not clinically significant screening safety labs

Exclusion Criteria

1. Females of childbearing potential not using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices) during the study

2. Diabetes mellitus requiring treatment other than diet and exercise

3. Subjects with chronic moccasin type of T. pedis

4. Subjects with a history of having failed any previous topical antifungal therapy for their onychomycosis

5. Subjects unwilling to refrain from the use of nail cosmetics such as clear and or colored nail lacquers from the screening visit until the end of the study.

6. Subjects that have not undergone the specified washout period(s) for the following topical preparations or subjects who require the concurrent use of any of the following topical medications:

• Topical antifungal applied to the feet (does not include antifungals for treatment of T. pedis during the study): 4 weeks
• Anti-inflammatories, corticosteroids, topical immunomodulators: 2 weeks

7. Subjects that have not undergone the specified washout period(s) for the following systemic medications or subjects who require the concurrent use of any of the following systemic medications:

• Corticosteroids (including intramuscular injections): 2 weeks
• Antifungals for treatment of onychomycosis or any systemic antifungal with known activity against dermatophytes: 24 weeks
• Systemic immunomodulators: 4 weeks

8. Treatment of any type for cancer within the last 6 months

9. History of any significant internal disease

10. Subjects with a medical history of current or past psoriasis of the skin and/or nails

11. Concurrent lichen planus

12. Subjects who are known to be allergic to any of the test product(s) or any components in the test product(s) or history of hypersensitivity or allergic reactions to any of the study preparations as described in the Investigator's Brochure

13. Nail or anatomic abnormalities of the toe, e.g., genetic nail disorders, primentary disorders, onychogryphosis, trauma to the nail(s) to be treated

14. AIDS or AIDS related complex

15. History of street drug or alcohol abuse

16. Any subject not able to meet the study attendance requirements

17. Subjects who have participated in any other trial of an investigational drug or device within 60 days prior to enrollment or participation in a research study concurrent with this study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer

INDUSTRY

Sponsor Role: lead

Responsible Party

Anacor Pharmaceuticals, Inc.

Locations

Unidad de Investigación en Salud (UIS)

Chihuahua City, , Mexico

Hospital "Dr. Angel Leaño"

Guadalajara, , Mexico

Instituto Dermatologico Jalisciense

Guadalajara, , Mexico

Centro Dermatologico Pascua

Mexico City, , Mexico

CIF-BIOTEC Medica Sur.

Mexico City, , Mexico

IMIC

Mexico City, , Mexico

Hospital Universitario Dr. José Eleuterio González

Monterrey, , Mexico

MIRC / OCA Hospital

Monterrey, , Mexico

ISSEMYM

Toluca, , Mexico

Countries

Mexico

Other Identifiers

AN2690-ONYC-201 Cohort 1 and 2

Identifier Type: -

Identifier Source: org_study_id